Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Original IDE Cohort (Melody IDE)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: August 21, 2008
Last updated: October 31, 2016
Last verified: October 2016
No Study Results Posted on ClinicalTrials.gov for this Study
|Study Status:||This study is ongoing, but not recruiting participants.|
|Estimated Study Completion Date:||January 2020|
|Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Cheatham JP, Hellenbrand WE, Zahn EM, Jones TK, Berman DP, Vincent JA, McElhinney DB. Clinical and hemodynamic outcomes up to 7 years after transcatheter pulmonary valve replacement in the US melody valve investigational device exemption trial. Circulation. 2015 Jun 2;131(22):1960-70. doi: 10.1161/CIRCULATIONAHA.114.013588. Epub 2015 May 5.
McElhinney DB, Benson LN, Eicken A, Kreutzer J, Padera RF, Zahn EM. Infective endocarditis after transcatheter pulmonary valve replacement using the Melody valve: combined results of 3 prospective North American and European studies. Circ Cardiovasc Interv. 2013 Jun;6(3):292-300. doi: 10.1161/CIRCINTERVENTIONS.112.000087. Epub 2013 Jun 4.
McElhinney DB, Cheatham JP, Jones TK, Lock JE, Vincent JA, Zahn EM, Hellenbrand WE. Stent fracture, valve dysfunction, and right ventricular outflow tract reintervention after transcatheter pulmonary valve implantation: patient-related and procedural risk factors in the US Melody Valve Trial. Circ Cardiovasc Interv. 2011 Dec 1;4(6):602-14. doi: 10.1161/CIRCINTERVENTIONS.111.965616. Epub 2011 Nov 9.
McElhinney DB, Hellenbrand WE, Zahn EM, Jones TK, Cheatham JP, Lock JE, Vincent JA. Short- and medium-term outcomes after transcatheter pulmonary valve placement in the expanded multicenter US melody valve trial. Circulation. 2010 Aug 3;122(5):507-16. doi: 10.1161/CIRCULATIONAHA.109.921692. Epub 2010 Jul 19.